Fa'aaogā fa'amatalaga ma au'aunaga a le NEJM Group e sauni ai e avea ma foma'i, fa'aputu le poto, ta'ita'ia se fa'alapotopotoga tau soifua maloloina ma fa'alauiloa lau atina'e o galuega.
Ia Ianuari 2020, na amata ai ona iloilo e le US Food and Drug Administration (FDA) le tali atu a Amerika ia Covid-19.I le aso 4 o Fepuari, ina ua uma ona faʻasalalau se faʻalavelave faʻafuaseʻi o le soifua maloloina lautele, na matou amata faʻatagaina suʻega e faʻamaonia ai faʻamaʻi pipisi.I se faʻalavelave faʻafuaseʻi, e mafai e le FDA ona tuʻuina atu se faʻatagaina faʻaaogaina faʻafuaseʻi (EUA) mo oloa faʻafomaʻi e faʻavae i luga o le iloiloga o faʻamaoniga faasaienisi.O le faʻaaogaina o tulaga maualalo o le EUA, nai lo le faʻatali mo le faʻatagaina atoatoa e maua ai faʻamaoniga lautele, e mafai ona faʻavavevaveina le saoasaoa o le mauaina o suʻega saʻo.A maeʻa ona lipotia mataupu asymptomatic, e manino lava e manaʻomia ona tatou faʻaogaina isi taʻiala e malamalama ai i le salalau moni o le SARS-CoV-2 i le atunuʻu.I le taimi o le fa'ama'i muamua o le virus, e le'i faia su'ega serological (ie, antibody) pe fa'atapula'aina le fa'aoga.Ae ui i lea, i lenei tulaga, ua iloa e le FDA o le faʻamautinoaina vave ma lava le avanoa i suʻega serological i le Iunaite Setete e mafai ona faʻalauiloaina suʻesuʻega faʻasaienisi ma malamalama o Covid-19, ma fesoasoani e tali atu i le atunuʻu.
O su'ega serological e mafai ona iloa ai le tali atu a le tino i fa'ama'i ua mavae.Ole mea lea, ole su'ega serological na'o ia e le mafai ona iloa pe o lo'o a'afia se tagata ile SARS-CoV-2.E le gata i lea, e ui lava o le aafiaga o isi siama ua faʻaalia ai o le i ai o le SARS-CoV-2 antibodies e mafai ona maua ai se puipuiga mai le toe faʻamaʻi, matou te le iloa pe o iai ni antibodies?Po o se tulaga faapitoa o antibodies?O lona uiga e iai le puipuiga o le tagata e toe maua ai, ma afai o lea, o le a le umi e tumau ai lea puipuiga?
Ina ia faʻafaigofie le vave maua o suʻega serological e fale suʻesuʻe ma tausi soifua maloloina, na tuʻuina atu e le FDA taʻiala ia Mati 16. O taʻiala e mafai ai e le au atinaʻe ona faʻalauiloa a latou suʻega e aunoa ma le EUA.Afai lava e pasi le su'ega i le fa'amaoniga, o le a logoina i latou.FDA, ma le lipoti o le suʻega o loʻo i ai faʻamatalaga taua e uiga i tapulaʻa, e aofia ai se faʻamatalaga e leʻi toe iloiloina e le FDA le suʻega ma e le mafai ona faʻaogaina iʻuga e suʻesuʻe pe faʻasaʻo ai faʻamaʻi.1
I lena taimi, e le masani ona faʻaaogaina suʻega serological i le tausiga o maʻi.Matou te fa'atinoina isi puipuiga e ala i le fa'atapula'aina o lona fa'aogaina i fale su'esu'e ua fa'atagaina e Medicare ma Medicaid Services Centres e fa'atino ai su'ega lavelave maualuga e tusa ai ma le Teuteuga o le Fa'aleleia o Fale Su'esu'e (CLIA).O ia fale su'esu'e e iai tagata faigaluega e fa'atatau i le fa'atinoga o su'ega ma filifili le su'ega sili mo se fa'amoemoe.O ofisa atia'e o lo'o fa'amoemoe e fa'aoga su'ega serological i le fale po'o le nofoaga o tausiga (fa'ata'ita'iga foma'i) (se'i vagana ua puipuia e le tusipasi a le CLIA a le falesu'esu'e) e tatau lava ona tu'uina atu se talosaga a le EUA ma fa'atagaina e le FDA mo a latou su'ega.Matou te fuafua e toe iloilo lenei faiga fa'avae pe a uma ona fa'atagaina ni su'ega serological.Ae ui i lea, i le toe mafaufau i ai, na matou iloa ai o faiga faʻavae o loʻo faʻamatalaina i la matou taʻiala Mati 16 e sese.
E oʻo atu i le faʻaiʻuga o Mati, 37 kamupani gaosi oloa na logoina le FDA i le latou faʻaofiina o suʻega serological i le maketi a Amerika.Na maua e le FDA le talosaga a le EUA mo suʻega serological ma amata faʻatagaina le suʻega muamua ia Aperila.Ae ui i lea, i le amataga o Aperila, na amata ai e le au ofisa o le malo ona faʻaalia le ono aʻafiaga o nei suʻega i le toe tatalaina o le tamaoaiga ma tuʻuina atu inisiua mo faʻaoga e le lagolagoina e le saienisi ma e le ausia tapulaʻa na faʻatulaga e le FDA.O le iʻuga, o loʻo lolovaia le maketi i suʻega serological, o nisi o loʻo i ai iʻuga leaga, ma o le tele o loʻo faʻatau atu i auala e feteenai ma tulafono a le FDA.E oʻo atu i le faʻaiuga o Aperila, 164 kamupani gaosi oloa na logoina le FDA na latou faia suʻega serological.O lenei fa'asologa o mea na tutupu e ese mai lo matou poto masani i su'ega fa'atau fa'atau.I lenei tulaga, e itiiti ni suʻega e tuʻuina atu i lalo o le faʻaaliga;e masani ona fa'alauiloa e le au gaosi a latou lava su'ega nai lo le lisiina o oloa na faia e isi, e masani lava e le o ni US gaosi oloa, pei o nisi su'ega serological;fa'amatalaga sese ma fa'amaumauga E la'ititi lava tulaga o fa'alavelave.
I le aso 17 o Aperila, na tuʻuina atu ai e le FDA se tusi i le auʻaunaga faʻafomaʻi e faʻamatalaina ai o nisi atiaʻe na latou faʻaleagaina le lisi o faʻamatalaga o pusa suʻega serological e fai mai pepelo ai o latou suʻega na faʻatagaina pe faʻatagaina e le lala sooupu.2 E ui lava e sili atu nai lo le 200 serological suʻega reagent developers, o le FDA ua ofo atu le EUA poʻo le fuafuaga e tuʻuina atu le EUA, o lea na suia ai e le FDA lana faiga faʻavae ia Me 4 ina ia mafai ai ona tatou iloiloina le faavae faasaienisi o faʻasalalauga faʻasalalau uma ma iloilo lona aoga. Feusuaiga.3 E oʻo mai ia Fepuari 1, 2021, ua faʻaleaogaina e le FDA le maliega.O se lisi o suʻega e 225 na lisiina mai la matou upega tafaʻilagi, 15 tusi lapataʻi na tuʻuina atu, ma faʻasalalauga faʻasalalau i fafo na tuʻuina atu i kamupani e 88.
I le taimi lava e tasi, talu mai Mati, o loʻo galulue faʻatasi le FDA ma National Institutes of Health (NIH), Centres for Disease Control and Prevention, ma le Ofisa mo Suʻesuʻega Maualuga ma Atinaʻe i Biomedicine e fesoasoani i le National Cancer Institute (NCI). faʻavae le gafatia e iloilo ai le serology.E fesoasoani e fa'ailoa fa'ai'uga fa'atonutonu a le FDA i su'ega ta'itasi (https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-publicly-shares-antibody-test-performance-data - kits-vaega-fa'amaonia).O le vaega su'esu'e na fa'apotopotoina e le NCI e aofia ai le 30 fa'aaisa SARS-CoV-2 antibody-positive serum samples ma le 80 fa'aaisa antibody-negative serum ma anticoagulated citrate glucose solution formula A plasma samples.Ole tele ma le tu'ufa'atasiga o le laulau na filifilia ina ia mafai ai e su'esu'ega fa'avae su'esu'e ma tu'uina atu fa'atatau talafeagai ma va'aiga mautinoa mo le fa'atinoga o su'ega i lalo ole avanoa fa'ata'ita'i fa'atapula'a.O lenei galuega o le taimi muamua lea na faia ai e le malo feterale se iloiloga a le tagata lava ia e logoina ai le FDA o le faatagaga.Mulimuli ane, na faʻaogaina e le National Institutes of Health (NIH) lana vaʻaiga ma le nofoaga autu o aʻoaʻoga e faʻatautaia ai suʻesuʻega muamua o nofoaga faʻamoemoeina o le tausiga ma fale faʻataʻitaʻiga Covid-19 i lalo o lana polokalame RADx (Rapid Diagnostic Acceleration).4
Ua uma ona matou faʻamatalaina muamua o matou poto masani i suʻega faʻamaonia Covid-19.5 Fa'amatalaga talafeagai ma tagata auai-ma gaioiga a le FDA?E ese foʻi le tulaga o suʻega serological, ma e ese foʻi lesona ua tatou aʻoaʻoina.
Muamua, o lo matou poto masani i suʻega serological e faʻamamafaina ai le taua o le faʻatagaina tutoʻatasi o oloa faʻafomaʻi i luga o se faʻasaienisi faʻasaienisi, ma e le faʻatagaina oloa suʻega e le faʻatagaina e ulufale i le maketi.O le iloaina o le mea ua tatou iloa nei, e tusa lava pe leai ni tapulaa na matou faia muamua, matou te le faʻatagaina suʻega serological e aunoa ma le iloiloga ma le faʻatagaina a le FDA.E ui lava o isi mea e ono mafua ai le lolovaia o oloa e le faʻatagaina i totonu o le maketi, o la matou faiga faʻavae Mati 16 e mafai ai ona tupu lenei mea.
Lona lua, i le avea ai o se vaega o le faʻamaʻi fuafuaga, e tatau i le malo feterale ona faʻamaopoopoina le saunia o polokalame suʻesuʻe a le malo ma le tumaoti e foia ai faʻafitauli faʻamaʻi e fesoʻotaʻi ma faʻamaʻi pipisi ma le puipuiga i le amataga o se faʻamaʻi.O se taumafaiga tu'ufa'atasi o le a fesoasoani e fa'amautinoa o lo'o fa'atinoina su'esu'ega mana'omia i se taimi talafeagai, fa'aitiitia le toe fa'aluaina o su'esu'ega, ma fa'aoga atoatoa mea a le feterale.
Tolu, e tatau ona tatou faʻavaeina le tomai e iloilo ai le faʻatinoga o suʻega i totonu o le feterale poʻo le sui o le feterale aʻo leʻi oʻo i le faʻamaʻi, ina ia mafai ai ona faʻataunuʻuina vave iloiloga tutoatasi i le taimi o le faʻamaʻi.O la matou galulue fa'atasi ma le NCI ua fa'aalia ai le taua o lenei faiga.Faʻatasi ma le faʻatagaina a le FDA, o lenei taʻiala e mafai ona faʻatagaina vave ma tutoʻatasi le iloiloga o le saʻo o suʻesuʻega mole, antigen ma suʻega serological, ma faʻaitiitia le manaʻoga mo tagata atiaʻe e suʻe faʻataʻitaʻiga maʻi poʻo isi faʻataʻitaʻiga faʻataʻitaʻiga e faʻamaonia ai a latou suʻega, faʻavavevave le faʻaogaina o le saʻo. ua fa'aleleia su'ega.E tatau foi i le malo tele ona mafaufau e faʻaoga lenei metotia i tekinolosi faʻaaogaina i fafo atu o le faʻamaʻi.Mo se faʻataʻitaʻiga, o le polokalame RADx a le NIH e mafai ona faʻaauau ma faʻalautele i tua atu o Covid-19.I le taimi umi, matou te manaʻomia se auala masani e faʻamaonia ai le suʻega suʻega ma le faʻatinoga.
Lona fa, e tatau i le sosaiete faʻasaienisi ma fomaʻi ona malamalama i le faʻamoemoega ma le faʻaogaina o suʻega serological, ma pe faʻafefea ona faʻaoga tatau iʻuga o suʻega e faʻailoa ai le tausiga lautele.Faatasi ai ma le atinaʻeina o le poto faʻasaienisi, faʻaauau aʻoaʻoga e manaʻomia i soʻo se faʻalavelave faʻafuaseʻi o le soifua maloloina lautele, aemaise lava le manatu o metotia suʻega serological e faʻaaoga sese mo suʻesuʻega, ma o tagata e maualalo le faʻamaʻi pipisi e mafai ona faʻaogaina se metotia suʻega e tasi.O le a iai ni fa'ai'uga lelei sese ma fa'aalia le puipuiga mai fa'ama'i.O a matou metotia su'ega e mana'omia le fa'afouina pea ma ta'ita'ia e le saienisi fa'atuatuaina.
Ma le mea mulimuli, o itu uma e a'afia i le tali atu i le soifua maloloina lautele e mana'omia ona maua fa'amatalaga sili atu vave.E pei lava ona taumafai vave fomaʻi e malamalama pe faʻafefea ona aʻafia tagata gasegase ma le auala e sili ona togafitia ai tagata mamaʻi, e tatau i le FDA ona faʻafetaui i faʻamatalaga faʻatapulaʻa ma faʻasolosolo, aemaise lava i le amataga o se faʻamaʻi.O le fa'atuina o faiga fa'ale-malo ma fa'ava-o-malo lelei ma fa'amaopoopo e aoina ai fa'amaoniga ma aoina, fa'asoa ma fa'asalalau fa'amatalaga e taua tele mo le fa'amutaina o fa'ama'i o lo'o iai nei ma tali atu i fa'alavelave fa'afuase'i o le soifua maloloina lautele.
I le va'ai i luma, a'o fa'atupula'ia le fa'ama'i, o le a fa'aauau pea ona faia e le FDA ni faiga e fa'amautinoa ai o lo'o sa'o ma fa'atuatuaina su'ega antibody e saunia i se taimi talafeagai e fa'afetaui ai mana'oga o le soifua maloloina lautele.
1. Puleaina o Meaai ma Vailaau.Le faiga faʻavae mo suʻesuʻega faʻamaonia mo le 2019 coronavirus faʻamaʻi i faʻalavelave faʻafuaseʻi o le soifua maloloina lautele.Mati 16, 2020 (https://web.archive.org/web/20200410023229/https://www.fda.gov/media/135659/download).
2. Puleaina o Meaai ma Vailaau.Tusi i tausi soifua maloloina e uiga i faʻamatalaga taua e uiga i le faʻaogaina o serology (antibodies) e iloa ai le COVID-19.Aperila 17, 2020 (faafou ia Iuni 19, 2020) (https://www.fda.gov/medical-devices/letters-health-care-providers/important-information-use-serological-antibody-tests- covid-19 -tusi ile tausi soifua maloloina).
3. Shah A ma ShurenJ.A'oa'o atili e uiga ile tulafono ole su'ega antibody ole FDA: Fa'amuamua le avanoa ma le sa'o.Silver Spring, MD, Food and Drug Administration (FDA), Me 4, 2020 (https://www.fda.gov/news-events/fda-voices/insight-fdas-revised-policy -antibody-tests-prioritizing- avanoa-ma-saʻo).
4. National Institutes of Health.Fa'asa'o Fa'avavevave (RADx) (https://www.nih.gov/research-training/medical-research-initiatives/radx).
5. Shuren J, Stenzel T. Covid-19 molecular diagnostic test na aʻoaʻoina se lesona.The English Journal of Medicine 2020;383(17): e97-e97.
Taimi meli: Mati-10-2021